Velcro cuff 1 tube, newborns,

Basic Information

• Brand Name: Velcro cuff 1 tube, newborns,
• Primary DI: 04045396215566
• Version / Model: 134.002
• Catalog Number: 134.002
• Company Name: Rudolf Riester GmbH
• Labeler DUNS: 537208717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-28
• Public Version: 1
• Public Version Date: 2021-02-05
• Public Version Status: New
• Public Device Record Key: 64c2eee0-818b-45a3-9b9f-6de603ef09ff

Device Description

Riester cuffs are used to generate pressure when measuring blood pressure.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXQ	Blood Pressure Cuff	Cardiovascular	870.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34978	Blood pressure cuff, reusable	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04045396215566	GS1

Premarket Submissions

Submission Number	Supplement Number
K942777	000